PEP-CMV + Nivolumab for Brain Cancer
(PRiME II Trial)
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients should not be on certain immunosuppressive agents or tumor-directed therapies. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the PEP-CMV + Nivolumab treatment for brain cancer?
Research suggests that targeting cytomegalovirus (CMV) antigens, which are present in glioblastoma (a type of brain cancer), can help the immune system recognize and kill cancer cells. This approach has shown promise in using the body's immune response to fight glioblastoma, indicating potential effectiveness for treatments like PEP-CMV.12345
Is the combination of PEP-CMV vaccine and Nivolumab safe for humans?
Nivolumab (also known as Opdivo) is generally considered safe, but it can cause immune-related side effects, such as colitis (inflammation of the colon), which may require treatment with steroids. The PEP-CMV vaccine is still being studied, and while it shows promise in boosting immune responses, its safety profile in humans is not fully established yet.678910
What makes the PEP-CMV + Nivolumab treatment unique for brain cancer?
The PEP-CMV + Nivolumab treatment is unique because it targets cytomegalovirus (CMV) antigens, which are present in glioblastoma (a type of brain cancer) but not in normal brain tissue, allowing the immune system to specifically attack the cancer cells. This approach combines a vaccine targeting CMV with Nivolumab, an immune checkpoint inhibitor, to enhance the immune response against the tumor.12111213
What is the purpose of this trial?
This is a multisite, phase I/II clinical trial in children and young adults with newly-diagnosed high-grade glioma (HGG), diffuse midline glioma (DMG) and recurrent HGG/DMG, Medulloblastoma (MB), or ependymoma (EPN) to determine the safety, immunogenicity, and efficacy of a CMV-directed peptide vaccine plus checkpoint blockade.
Research Team
Eric M Thompson, M.D.
Principal Investigator
Washington University School of Medicine
Eligibility Criteria
This trial is for children and young adults with new or recurrent high-grade gliomas, diffuse midline gliomas, medulloblastoma, or ependymoma. Participants must meet specific health criteria to ensure safety during the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive temozolomide and PEP-CMV vaccine during the induction cycle
Maintenance Treatment
Participants continue to receive PEP-CMV vaccine every 28 days until recurrence or progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Nivolumab
- PEP-CMV vaccine
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
National Cancer Institute (NCI)
Collaborator